MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. FABIUS PLUS; ANESTHESIA UNITS

Catalog Number 8606800

Device Problems Gas Output Problem (1266); Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189); Intermittent Communication Failure (4038); Misassembled During Installation (4049)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the machine control failed, and it could not provide breathing for the patient under general anesthesia, no health consequences have reportedly occurred.

Event Description

It was reported that the machine control failed, and it could not provide breathing for the patient under general anesthesia, no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that the machine control failed and it could not provide breathing for the patient during usage, so it could only be changed to manual control to provide breathing support for the patient.No harm was caused to the patient.After investigation on the log, the year of system date was set to 2034 instead of 2024.But there was no influence to the error log analysis.Only one error log occurred on 2034-04-21 shows system leakage test out of spec 350ml/min which may caused by loosing of the breathing hoses.And was recovered on next power on self test on 2034-04-27.So it was concluded that no device function failure was detected.Keep on monitoring similar cases.

• Brand Name: FABIUS PLUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai ; CH
• Manufacturer (Section G): SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai PRC-2 0120; CH PRC-201206
• Manufacturer Contact: 230 xin jin qiao road; shanghai PRC-2-0120 ; 2131086385
• MDR Report Key: 19154079
• MDR Text Key: 340738948
• Report Number: 3019545235-2023-00020
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1